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The role is split 50/50 between QP release activity and QA microbiology activity.
Is a member of the QP team responsible for product release ensuring customer service targets are met while regulatory compliance is maintained
Proactive role ensuring microbiological risk is minimised in the production environments.
Lead and assist in microbiological and quality investigations.
Duties & Responsibilities:
Microbiological risk awareness of hazards through training and education of staff
Use of risk assessments to reduce potential micro contamination
Control of the sites water supplies via the site water group to maintain quality of softened, purified and WFI supply loops
Assist quality team in their investigations when required
Support other departments on site as the micro specialist
Assist external compliance with auditing of microbiologically sensitive products or raw materials
Work with R&D on microbiologically sensitive projects affecting the Hull site
Is a member of the site QP team and is responsible for QP release of products manufactured on site and at 3rd parties
Key Role Information:
The site works at a very fast pace with a focus on the continual manufacturing of pharmaceutical products. The candidate must be able to make their view point very clear. The ability to demonstrate the potential risk to product quality is vital when dealing with all issues on site
The ability to communicate the risk of microbial contamination with key decision makers is essential
Certified / Qualified to act as a Qualified Person (QP)
A Degree life science discipline preferably in microbiology.
Industry experience in Pharmaceutical or Cosmetic Manufacturing
Non-sterile liquid dose form and CIP cleaning experience is essential
Experience of training